StudyGen 360 Support

Let’s Create
a Smarter Study
Data Management


Our dedicated support team is always available to ensure the smooth and efficient operation of your StudyGen 360 solution – whether it’s technical questions, troubleshooting, or optimization recommendations.

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Support StudyGen 360

Let’s Create a Smarter Study
Data Management

Supportcenter

Our dedicated support team is always available to ensure the smooth and efficient operation of your StudyGen 360 solution – whether it’s technical questions, troubleshooting, or optimization recommendations.

Take a look AT what drives our customers

StudyGen 360 Platform

The system flexibly supports both large pharmaceutical companies and small laboratory units, offering adaptable deployment models across on-premise and cloud environments. Its architecture can be tailored to diverse organizational structures and research needs.

The Watson-integrated solution is available as an on-premise deployment. For non-Watson solutions, the system can be deployed in the cloud, including private cloud environments. It supports AWS and can be adapted for other cloud providers.

StudyGen 360 is a comprehensive clinical study data platform, not just a LIMS. It integrates data from multiple sources (LIMS, SAP, Excel, databases) and provides automated GxP-compliant reporting with real-time analytics. Unlike traditional systems, it offers end-to-end data integrity from sample collection to final study report generation.

The cloud solution offers greater flexibility in data processing and analysis compared to the on-premise version. It uses modern database technologies instead of Oracle, reducing licensing costs. The cloud platform is built around a study-centric rather than sample-centric approach, allowing for more sophisticated data analysis across studies. It also provides enhanced scalability and easier updates.

StudyGen 360 uses a modern cloud-native architecture built on AWS services. It employs Lambda functions for serverless computing, allowing automatic scaling and improved security. Data is stored in encrypted S3 buckets and Aurora databases (MySQL/PostgreSQL variant). This architecture eliminates the need for traditional server infrastructure while providing enhanced scalability and security features.

The system adheres to ICH M10 guidelines, implementing robust security features like e-signatures, restricted access controls, and comprehensive audit trails. Its configurable validation processes ensure regulatory compliance across different research environments.

Implementation usually spans one month, involving collaborative process understanding, wizard-based configuration, and strategic system setup with minimal technical complexity.

StudyGen 360 is fully 21 CFR Part 11 compliant with built-in electronic signatures, comprehensive audit trails, and data integrity controls. All processes meet FDA regulations for electronic documentation. The system maintains complete traceability through versioning and provides human-readable archiving for regulatory submissions.

Yes, StudyGen 360 offers flexible deployment options to match your needs: on-premise for complete control, cloud for scalability, hybrid for best of both worlds, or SaaS for minimal IT overhead. Our „pay-per-use“ model ensures you only pay for what you actually use.

StudyGen 360 enables unprecedented transparency while maintaining separate data environments. CROs can efficiently communicate study progress and potential challenges, while sponsors gain earlier visibility into study trajectories. This reduces communication overhead, enables faster decision-making, and creates more dynamic partnerships at every trial phase.

StudyLAB

The main components include: Projects, Studies, Shipments (sample deliveries), Containers (boxes within shipments), Physical samples (individual samples with barcodes), Sample tracking, and Run sequences.

The structure is: Project → Study → Run → Assay. A project can contain multiple studies, and a study can use multiple assays (e.g., High Range and Low Range). The relationship between projects and assays is currently being refined.

Assays are defined independently and can be associated with multiple projects. When planning a run, only assays linked to the current study’s project(s) will be displayed to prevent selection errors.

StudyLab includes a project level above studies, where sponsors contain multiple studies. Projects group related studies (e.g., validation + main study) and can have multiple assays assigned. This allows for better organization of complex pharmaceutical development programs.

StudyREporter

The tool provides immediate out-of-the-box functionality with approximately one month of collaborative configuration. Most customizations can be achieved through a user-friendly wizard without extensive programming.

According to customer measurements, the solution saves approximately 70-80% of the total time spent on creating and verifying reports. While some manual work like adding comments and review processes remains necessary, the automated data transfer and verification significantly reduces the overall effort.

The system offers high flexibility through its experiment concept. Users can define different ways of looking at data, create interactive selection mechanisms, and implement various calculation methods. The platform supports both standardized workflows for regulated environments and more flexible approaches for research and development work. The cloud platform particularly excels at handling variable experiments and data analysis requirements.

The system is being developed to support comprehensive data review across different studies and batches. It will allow comparison of chromatograms, analysis of outliers, evaluation of internal standards, and other cross-study analyses. This capability is particularly valuable for reviewing data from different sites or comparing studies over time.

The system is expanding its capabilities with innovative AI features that allow users to request analyses using natural language, simplifying complex data processing. By generating code based on user requirements and facilitating report modifications through natural language instructions, the AI enhances accessibility while maintaining security by processing only data structure information rather than sensitive data. These features are scheduled for upcoming system releases.

The system provides extensive reporting flexibility through customizable templates that adapt to different sponsor requirements. Users can modify column layouts, adjust data fields, and fine-tune number formats between decimal places and significant figures. Large datasets are handled efficiently with horizontal table splitting to maintain document readability, ensuring optimal presentation of complex data.

StudyAI

StudyAI uses a context-first approach that keeps all sensitive clinical data within your validated systems at all times. The AI operates with specialized domain knowledge without requiring access to actual study data, ensuring complete data integrity and regulatory compliance. All AI-generated analyses include full audit trails, documented methodologies, and validation steps that meet GxP requirements.

Yes, StudyAI is designed as an intelligent layer that seamlessly integrates with all common clinical systems including EDC platforms, CTMS, eTMF solutions, and LIMS. As part of the StudyGen 360 ecosystem, it can consolidate data from multiple sources including legacy systems and current platforms. The integration is flexible and customizable to match your specific workflow requirements.

StudyAI combines advanced Large Language Models with specialized clinical research domain knowledge, enabling it to understand complex scientific requests in natural language. When you ask for an analysis, the AI interprets your request within the clinical context and generates validated analysis modules that execute within your secure environment. The system understands study protocols, regulatory requirements, and clinical terminologies to provide accurate, contextual responses.

StudyAI independently manages data validation, quality checks, protocol compliance monitoring, safety signal detection, and regulatory report generation across all StudyGen 360 products. The AI continuously learns from your workflows and optimizes processes to reduce manual intervention by typically 60-80%. It operates autonomously while maintaining complete traceability and the ability to regenerate results as needed for audits.

StudyInsight

StudyInsight integrates with all major EDC systems (Medidata Rave, Veeva Vault, Oracle InForm), LIMS platforms (LabWare, SampleManager), CTMS systems, and laboratory instruments through direct API connections. The platform also supports legacy systems and Excel/CSV imports with real-time synchronization capabilities.

StudyInsight maintains full GCP, FDA 21 CFR Part 11, and EMA compliance through built-in validation rules, complete audit trails, and automated data integrity checks. All data transformations include electronic signatures, role-based access controls, and documented change control for regulatory submissions.

Unlike static reports, StudyInsight’s live tables update automatically as new study data is collected. They feature advanced filtering, sorting, and drill-down capabilities while maintaining complete data lineage and audit trails for regulatory compliance.

StudyInsight deployment typically takes 2-4 weeks using pre-configured connectors for major systems. The cloud-native architecture eliminates server requirements, and pilot implementations can be operational within one week for evaluation purposes.

StudyPLUS

Yes, while StudyPlus Archive is optimized for Thermo Scientific™ Watson LIMS™ integration, our configurable architecture supports interfaces with multiple laboratory systems and can consolidate data from various sources. The solution also allows manual file uploads and can be extended to integrate with your existing IT infrastructure and archive systems.

StudyPlus Archive is designed with built-in compliance for FDA 21 CFR Part 11 (sections 11.10(b) and 11.50). The system includes comprehensive audit trails, data integrity validation through checksum files with hash values, and follows GAMP 5 approach for validation. We provide complete validation documentation and are ISO 9001:2015 certified, minimizing your internal validation effort.

StudyPlus Archive generates study data in multiple formats including PDF/A (for long-term human-readable documentation), CSV and XML (for data processing), all organized in structured directory formats. The archived data remains accessible indefinitely without requiring Watson LIMS™ knowledge or additional applications, ensuring true long-term data accessibility.

Implementation is streamlined since StudyPlus Archive is vendor-qualified with full validation documentation available. The system is highly configurable – you can customize the scope of file generation, select specific Watson LIMS™ content to include, and configure various output formats for different purposes (regulatory submissions, research reviews, etc.). Most implementations can be completed with minimal internal validation effort using our GAMP 5 approach.

StudyConnect

StudyConnect delivers up to 70% time reduction in report creation while eliminating human errors. This allows your research teams to focus on scientific analysis rather than time-consuming data compilation and formatting tasks.

You’ll achieve a 50-70% reduction in regulatory compliance burden with near-zero regulatory findings during inspections. Our system accelerates submission timelines, helping you shave months off your time to market.

Yes, StudyConnect supports large & small molecules with HPLC and LCMS reports, multi-run assay control for risk mitigation, immunogenicity testing, and pharmaceutical stability reporting – all with seamless data integration.

Absolutely. StudyConnect scales with your needs, whether you’re a small research lab or a large pharmaceutical company. From bioanalytical studies to stability reporting, we provide universal data integration across any lab size.

Individual Service Arrangements

Your StudyGen 360 Support from a Single Source

Our comprehensive support service provides you with the confidence you need for the daily operation of your systems. We offer various support levels to meet your specific requirements, from standard business hours support to 24/7 availability. In addition to reactive support, we also provide proactive maintenance and regular system checks to identify and resolve potential issues before they impact your operations. Our support portfolio includes:

  • Personal Support
  • Extended Support Services
  • Upgrade Consulting
  • Response Time by Specific Arrangements

You did not find what you expected?

Supportcenter
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Individual Service Arrangements

Your StudyGen 360 Support from a Single Source

Our comprehensive support service provides you with the confidence you need for the daily operation of your systems. We offer various support levels to meet your specific requirements, from standard business hours support to 24/7 availability. In addition to reactive support, we also provide proactive maintenance and regular system checks to identify and resolve potential issues before they impact your operations. Our support portfolio includes:

  • Personal Support
  • Extended Support Services
  • Upgrade Consulting
  • Response Time by Specific Arrangements

You did not find what you expected?

Supportcenter
up to data Jobs | Stylized illustration of person in pink shirt looking through binoculars with decorative leaves on transparent background